Infliximab administered as 3-dose induction followed by scheduled maintenance therapy in IBD: comparable clinical outcomes with or without concomitant immunomodulators

Abstract

To assess whether concomitant immunomodulator therapy with infliximab (IFX) is associated with better clinical outcomes when 3-dose induction followed by scheduled maintenance therapy is used in inflammatory bowel disease (IBD), efficacy data from pivotal trials in Crohn's disease and ulcerative colitis (ACCENT I & II, ACT I & II) were compared. As shown in the table below, response and remission rates did not differ significantly when IFX was used with and without concomitant immunomodulators. While there was a trend in favor of concomitant immunomodulators in some trials, there was a trend against them in other trials. Three of the four trials showed a trend toward fewer hospitalizations when concomitant immunomodulators were used, and this trend was most pronounced in ACCENT I (luminal Crohn's disease (CD)). The use of concomitant immunomodulators in patients receiving scheduled maintenance IFX therapy for IBD does not improve clinical outcomes over 54 weeks. Whether concomitant immunomodulators would improve clinical outcomes in patients treated beyond 1 year is unknown. Hospitalization rates may be lower with the use of concomitant immunomodulators, especially in CD. The benefits and risks of these agents in combination with IFX must be carefully weighed. The use of concomitant immunomodulators in patients receiving scheduled maintenance IFX therapy for IBD should be considered optional, not mandatory.